Chrona reads. Humans write.
Chrona Bio reads across your IND documents, finds the inconsistencies and missing evidence that trigger Information Requests, and gets you to Submission Clean — while your team keeps writing in Word and storing files where they already live.
chrona reads. humans write.
02 — The real problem
Contributors are scattered across modules. CMC writes in one document, clinical writes in another, the nonclinical contractor delivers PDFs from a vendor portal. Months pass between when a section is written and when it's reviewed.
No tool reads across documents the way a regulator does — pulling one number from Module 2.5, the same number from Module 3.2.P.2, and asking whether they agree. So you don't know what disagrees until the IR arrives and the clock stops on the project.
By the time the Information Request is in your inbox, the team that wrote the original sections has rolled off, the rationale lives in a Slack thread nobody saved, and you have ten business days.
03 — What Chrona catches · what Chrona tells you
04 — What you stop doing
05 — The readiness layer
Submission Clean is what you can defend on inspection day: zero unresolved critical findings, every section signed off, every comment dispositioned, every override documented with rationale and timestamp.
It isn't a milestone you hit the night before filing. It's the readout of a practice that runs every day — Chrona reading across the package while contributors keep writing, and surfacing the gaps before they become Information Requests.
05.5 — How it works
06 — Products
07 — Where Chrona fits
08 — Trust
09 — Mission
Through our partnership with CTD Commons, Chrona is informed by a public archive of complete IND portfolios — including the FDA correspondence that followed. That means the product knows what an inspector actually asks, not what a vendor template thinks they'll ask. Small teams get the institutional memory only large teams used to have.
10 — Writing
Practice guide · By Brian Vannoy
FDA's AI Clinical Trials Pilot Is a Documentation ProblemFDA's RFI on AI-enabled early-phase trials is a signal, not a rule. What regulatory writers should document about AI-assisted work — ALCOA+ and Part 11 applied to a new kind of input, with a concrete recipe for Word and SharePoint shops.
11 — Talk to us
Enterprise design partners, Pro early access, or just a question about how Chrona works on your submission — Brian and Flavia answer their own inbox.
Talk to Brian or Flavia